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Northwestern Survey Finds FDA Predictability a Top Concern Among Medtech Firms; Europe Preferred for Product Approval
Date:5/24/2011

urvey, investigators queried product designers and developers, entrepreneurs, academic physician inventors, and regulatory affairs professionals -- all of whom have been involved with the submission of 510(k) products in the past three years.

The survey is part of a larger study, "A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform." Over the next several months, investigators intend to expand on the survey findings by compiling case studies and performing a more in-depth examination of the U.S. and EU regulatory processes.

The survey builds on the investigators' previous InHealth-funded research with colleagues at Stanford that for the first time documented in detail the medical technology development process. That study, published in the June 2009 issue of the Journal of Medical Devices, found that almost half of all activities and decisions in the development process are affected by regulatory requirements.

The study is funded by the Institute for Health Technology Studies (InHealth), a nonprofit foundation that supports research and analysis into the role of medical technology in advancing healthcare and patient quality of life.

About InHealth (www.inhealth.org) Launched in 2004, the Institute for Health Technology Studies is a nonprofit research and educational organization supporting independent analyses of the social and economic effects of diagnostic and therapeutic medical devices.Contact: Robyn Stein/Caitlin Hool212-220-4444robyn.stein@gabbe.com / caitlin.hool@gabbe.com<
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SOURCE The Institute for Health Technology Studies (InHealth)
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